The invention relates to methods and compositions for the detection of Helicobacter pylori.
Helicobacter pylori is a urease-positive, microaerophilic, Gram-negative bacterium associated with gastritis, chronic gastritis, peptic ulcer disease, and gastric tumors in humans (Drumm et al. 1987 N. Engl. J. Med. 316:1557-1561; Jones et al. 1984 J. Clin. Pathol. 37:1002-1006; Marshall et al. 1984 Lancet i:1311-1315).
Attempts to detect Helicobacer pylori in clinical samples by culture of the organism have met with limited success due to the fastidious nature of the organism and the difficulties inherent in its selective growth. These problems are further complicated by the low number of organisms which may be present in the typical clinical sample, even when the sample is obtained by biopsy of gastric material. Attempts to diagnose Helicobacter pylori infection by detection of the organism in a sample obtained by less invasive techniques (e.g. saliva) has previously provided inconsistent results (Ferguson et al. 1993 J. Clin. Microbiol. 31:2802-2804). Serological diagnostic methods are more sensitive, but are not necessarily indicative of an active infection. Thus, there is a need for a simple, rapid detection method for detection of Helicobacter pylori which is not labor intensive and does not require growth conditions which can only be simulated in a laboratory setting.